Abstract
Purpose
To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal 1 mg triamcinolone acetonide (IVT) in center-involved diabetic macular edema.
Methods
In this randomized clinical trial study, ninety-two eyes of 46 patients with bilateral center-involved diabetic macular edema and no previous treatment were included in the study. One eye of each patient was randomly assigned to 1.25 mg of IVB injection or combination of 1.25 IVB and 1 mg IVT. Evaluation of best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) and grading of lens opacity was conducted at baseline, and weeks 2, 4, 6, 8, 12 and 24 after treatment. Retreatment was performed at a 6-week interval whenever indicated based on CMT.
Results
Between the groups, BCVA changes were not statistically different until 24-week follow-up (P > 0.05), but at 24 weeks after treatment, BCVA improvement was significantly better in IVB group (P = 0.049). Significant CMT reduction was observed in each group along the follow-up period (P = 0.001). The mean CMT reduction was more significant in combination (IVB + IVT) group at 2 weeks of follow-up (P < 0.001), but CMT changes were not significant between the groups at weeks 12th and 24th after injection. Overall, retreatment was applied for 59 eyes up to 24 weeks (33 in the IVB group, 26 in the IVB + IVT group). Among patients with 2 or more injections, number of injections was significantly lower in IVB + IVT group (P = 0.043). Three eyes within IVB + IVT group developed IOP rise beyond 21 mmHg, which were controlled with topical anti-glaucoma medications within 1 week. Changes in lens opacity were not significant between two groups.
Conclusion
Eyes treated with IVB plus 1 mg IVT injections had more significant reduction in CMT in early post-injection, but this effect was transient. Although after 24 weeks visual acuity improvement was better in IVB group, combination therapy may decrease the number of injections. Combining 1 mg of intravitreal triamcinolone with bevacizumab was not accompanied with significant side effects.
Similar content being viewed by others
References
Munoz B, West SK, Rubin GS et al (2000) Causes of blindness and visual impairment in a population of older Americans: the Salisbury Eye Evaluation Study. Arch Ophthalmol 118:819–825
Moss SE, Klein R, Klein BE (1998) The 14-year incidence of visual loss in a diabetic population. Ophthalmology 105:998–1003
Yau JW, Sl Rogers, Kawasaki R et al (2012) Meta-analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care 35:556–564
Klein BEK, Myers CE, Howard KP, Klein R (2015) Serum lipids and proliferative diabetic retinopathy and macular edema in persons with long term type 1 diabetes: the Wisconsin epidemiologic study of diabetic retinopathy. JAMA Ophthalmol 133(5):503–510
Early Treatment Diabetic Retinopathy Study Research Group (1985) Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol 103:1796–1805
Early Treatment Diabetic Retinopathy Study Research Group (1995) Focal photocoagulation treatment of diabetic macular edema: relationship of treatment effect to fluorescein angiographic and other retinal characteristics at baseline: ETDRS report no. 19. Arch Ophthalmol 113:1144–1155
Tranos PG, Wickremasinghe SS, Stangos NT et al (2004) Macular edema. Surv Ophthalmol 49:470–490
Arnarsson A, Stefansson E (2000) Laser treatment and the mechanism of edema reduction in branch retinal vein occlusion. Invest Ophthalmol Vis Sci 41(3):877–879
Chun DW, Heier JS, Topping TM et al (2006) A pilot study of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema. Ophthalmology 113:1706–1712
Rakhee A, Ajay A, Sagdeo M (2014) Effect of combined intravitreal injections of bevacizumab and triamcinolone acetonide vs intravitreal bevacizumab in diffuse diabetic macular edema. IOSR J Dent Med Sci: IOSR-JDMS 13(6 Ver. IV):01–06
Caldwell RB, Bartoli M, Behzadian MA et al (2003) Vascular endothelial growth factor and diabetic retinopathy: pathophysiological mechanisms and treatment perspectives. Diabetes Metab Res Rev 19:442–455
Antcliff RJ, Marshall J (1999) The pathogenesis of edema in diabetic maculopathy. Semin Ophthalmol 14:223–232
Gillies MC, Sutter FK, Simpson JM et al (2006) Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology 113:1533–1538
Kriechbaum K, Prager S, Mylonas G (2014) Intravitreal bevacizumab (Avastin) versus triamcinolone (Volon A) for treatment of diabetic macular edema: one-year results. Eye 28:9–16
Paccola L, Costa RA, Folgosa MS et al (2008) Intravitreal triamcinolone versus bevacizumab for treatment of refractory diabetic macular oedema (IBEME study). Br J Ophthalmol 92(1):76–80
Audren F, Lecleire-Collet A, Erginay A et al (2006) Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg. Am J Ophthalmol 142:794–799
Commertial Diabetic Retinopathy Clinical Research N (2015) Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med 372:1193–1203
Faghihi H, Roohipour R, Mohammadi SF et al (2008) Intravitreal bevacizumab versus combined bevacizumab-triamcinolone versus macular laser photocoagulation in diabetic macular edema. Eur J Ophthalmol 18(6):941–948
Soheilian M, Ramezani A, Obudi A et al (2009) Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology 116:1142–1150
Wykoff CC, Elman MJ, Regillo CD, Ding B, Lu N, Stoilov I (2016) Predictors of diabetic macular edema treatment frequency with ranibizumab during the open-label extension of the RIDE and RISE trials. Ophthalmology 123(8):1716–1721
Radwan SH, Soliman AZ, Tokarev J, Zhang L, van Kuijk FJ, Koozekanani DD (2015) Association of disorganization of retinal inner layers with vision after resolution of center-involved diabetic macular edema. JAMA Ophthalmol 133(7):820–825
Mitchell P, Bandello F, Schmidt-Erfurth U et al (2011) The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology 118(4):615–625
Shimura M, Nakazawa T, Yasuda K et al (2008) Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on persistent diffuse diabetic macular edema. Am J Ophthalmol 145(5):854–861
Soheilian M, Garfami KH, Ramezani A, Yaseri M, Peyman GA (2012) Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina 32(2):314–321
Lim JW (2012) Comparison of intravitreal bevacizumab alone or combined with triamcinolone versus triamcinolone in diabetic macular edema: a randomized clinical trial. Ophthalmoloqica 227(2):100–106. doi:10.1159/000331935
Synek S, Vesely P (2011) Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular oedema. Coll Antropol 35(3):841–845
Liu X et al (2014) Intravitreal bevacizumab with or without triamcinolone acetonide for diabetic macular edema: a meta-analysis of randomized controlled trials. Chin Med J 127(19):3471–3476
Shoeibi N, Ahmadieh H, Entezari M, Yaseri M (2014) Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema: long-term results of a clinical trial. J Ophthalmic Vis Res 8(2):99–106
Diabetic Retinopathy Clinical Research N, Scott IU, Edwards AR, Beck RW, Bressler NM, Chan CK et al (2007) A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology 114(10):1860–1867
Browning DJ, Glassman AR, Aiello LP et al (2007) Relationship between optical coherence tomography-measured central retinal thickness and visual acuity in diabetic macular edema. Ophthalmology 114(3):525–536
Schmid KE, Neumaier-Ammerer B, Stolba U, Binder S (2006) Effect of grid laser photocoagulation in diffuse diabetic macular edema in correlation to glycosylated haemoglobin (HbA1c). Graefes Arch Clin Exp Ophthalmol 244:1446–1452
Jonas JB, Martus P, Degenring RF et al (2005) Predictive factors for visual acuity after intravitreal triamcinolone treatment for diabetic macular edema. Arch Ophthalmol 123(10):1338–1343
Diabetic Retinopathy Clinical Research N (2008) A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology 115(9):1447–449, 9e1–9e10
Cunha-Vaz J, Ashton P, Iezzi R et al (2014) Sustained delivery fluocinolone acetonide vitreous implants. Ophthalmology 121:1892–1903
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors declare that they have no conflict of interest.
Rights and permissions
About this article
Cite this article
Riazi-Esfahani, M., Riazi-Esfahani, H., Ahmadraji, A. et al. Intravitreal bevacizumab alone or combined with 1 mg triamcinolone in diabetic macular edema: a randomized clinical trial. Int Ophthalmol 38, 585–598 (2018). https://doi.org/10.1007/s10792-017-0496-4
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10792-017-0496-4